Application Sponsors
ANDA 090392 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | TABLET;ORAL | 5MG | 0 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2011-02-24 | |
LABELING; Labeling | SUPPL | 2 | AP | 2012-11-29 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2021-04-05 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2021-04-05 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 4 | Null | 7 |
SUPPL | 5 | Null | 7 |
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 90392
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LEVOCETIRIZINE DIHYDROCHLORIDE","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LEVOCETIRIZINE DIHYDROCHLORIDE","submission":"LEVOCETIRIZINE DIHYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)